Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 30, 2011
Last updated: May 28, 2014
Last verified: May 2014

With the new reimbursement criteria, we want:

To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.

To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

Condition Intervention
Plaque Psoriasis Patients
Other: Enbrel treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Weeks of Etanercept Treatment [ Time Frame: Baseline up to end of study (90 weeks) ] [ Designated as safety issue: No ]
    Average duration of time in weeks for treatment with etanercept was reported.

Secondary Outcome Measures:
  • Number of Weeks of Off-Treatment [ Time Frame: Baseline up to end of study (90 weeks) ] [ Designated as safety issue: No ]
    Total duration of time in weeks for which participants discontinued etanercept treatment was reported.

  • Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Start and end of cycle 1, 2, 3 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.

  • Percentage of Body Surface Area (BSA) Affected by Psoriasis [ Time Frame: Start and end of cycle 1, 2, 3 ] [ Designated as safety issue: No ]
    Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.

  • Number of Participants With Reasons for Treatmant Discontinuation [ Time Frame: Baseline up to end of study (90 weeks) ] [ Designated as safety issue: No ]
    Number of participants who discontinued etanercept before completing the study was reported.

Other Outcome Measures:
  • Number of Participants Who Received Continuous Treatment [ Time Frame: Baseline up to end of study (90 weeks) ] [ Designated as safety issue: No ]
    Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.

  • Number of Participants Who Received Intermittent Treatment [ Time Frame: Baseline up to end of study (90 weeks) ] [ Designated as safety issue: No ]
    Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.

Enrollment: 140
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria
Other: Enbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly

Detailed Description:

100 patients will be followed for at least 1 year


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion. It is requested to include patients in a consecutive manner as much as possible.


Inclusion Criteria:

  • Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
  • Patients ≥18 year
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01557283

Herestraat 49
Leuven, Belgium, 3000
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01557283     History of Changes
Other Study ID Numbers: B1801314, BEFLEX
Study First Received: September 30, 2011
Results First Received: May 28, 2014
Last Updated: May 28, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 25, 2015